Erectile Dysfunction
Conditions
Keywords
Bioavailability Food Effect Oral Dissolving Tablet (ODT)
Brief summary
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
Interventions
DRUGSildenafil
Orally Disintegrating Tablet, 50 mg, Single Dose
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction. * Body Mass Index (BMI) of 17.5 to 32.5 kg/m2. * Signed Informed Consent.
Exclusion criteria
* Evidence or history of clinically significant abnormalities * Have baseline orthostatic hypotension * Positive drug screen, excessive alcohol and tobacco use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose | Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose | AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). |
| Plasma Decay Half Life (t1/2) | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive sildenafil 50 mg ODT under fasted condition first and sildenafil 50 mg ODT under fed condition first. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 12 | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose
Population: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sildenafil 50 mg (Fasted) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 813.20 ng*hr/mL | Standard Deviation 186.29 |
| Sildenafil 50 mg (Fed) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 712.80 ng*hr/mL | Standard Deviation 245.58 |
Comparison: Natural log transformed AUClast of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.90% CI: [77.62, 98.99]
Primary
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Population: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sildenafil 50 mg (Fasted) | Maximum Observed Plasma Concentration (Cmax) | 292.60 ng/mL | Standard Deviation 93.84 |
| Sildenafil 50 mg (Fed) | Maximum Observed Plasma Concentration (Cmax) | 121.00 ng/mL | Standard Deviation 56.92 |
Comparison: Natural log transformed Cmax of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.90% CI: [32.4, 52.76]
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Population: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sildenafil 50 mg (Fasted) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] | 838.60 ng*hr/mL | Standard Deviation 197.2 |
| Sildenafil 50 mg (Fed) | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] | 804.00 ng*hr/mL | Standard Deviation 284.69 |
Comparison: Natural log transformed AUC (0-∞) of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.90% CI: [80.23, 108.78]
Secondary
Plasma Decay Half Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Population: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sildenafil 50 mg (Fasted) | Plasma Decay Half Life (t1/2) | 3.039 hrs | Standard Deviation 0.484 |
| Sildenafil 50 mg (Fed) | Plasma Decay Half Life (t1/2) | 2.503 hrs | Standard Deviation 0.359 |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Population: Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sildenafil 50 mg (Fasted) | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.625 hrs |
| Sildenafil 50 mg (Fed) | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 4.000 hrs |